Strong HCV clearance data for R1626 regimen

R1626, one of Swiss drug major Roche's new investigational drugs for hepatitis C, has shown promising antiviral efficacy when given in combination with Pegasys (peginterferon alfa-2a (40KD)) and Copegus (ribavirin), according to data presented at the American Association for the Study of the Liver meeting, in Boston, Massachussetts. After four weeks of treatment with the triple combination, HCV could no longer be detected in up to 81% of patients. Those on the triple combination had a mean decrease in viral load of 5.2 log10 from baseline, indicating a robust and rapid virological response.

The study found that up to 81% of those patients treated with R1626 1,500mg plus Pegasys and Copegus had an undetectable HCV viral load by week four (mean reduction of 5.2 log10 IU/mL). ALT, a liver enzyme, normalized in approximately 50% of patients in R1626 treatment groups. "The results from this Phase IIa study show that R1626 has a profound effect when used in combination with Pegasys plus Copegus," said Paul Pockros, the lead investigator of the study. "The synergistic antiviral effect of R1626 along with the lack of resistance means that R1626 could be an exciting antiviral drug for the treatment options for patients with hepatitis C if a safe and acceptable dosage regimen can be determined in future studies," he added.

The novel polymerase inhibitor also demonstrated a high barrier to the development of resistance, according to a second abstract presented at the AASLD. Resistance to R1626 was not identified following intensive testing for either two weeks of treatment with the agent as monotherapy or in patients treated with R1626 for four weeks in combination with the standard-of-care.